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Uloric Background Information
Uloric (febuxostat) was approved in 2008 and marketed early 2009 for the treatment of the chronic management of hyperuricemia in gout, a variation of arthritis. Uloric was the first gout medication approved by the FDA in 40+ years. Uloric was marketed and sold as the new upgraded gout medication over its predecessor, allopurinol.
Timeline of Events
- 2005 : Takeda Pharmaceuticals presents their new gout drug, Uloric, to the FDA for approval. The FDA refused the new medication’s approval due to the higher rates of cardiac events occurring during drug trials compared to allopurinol.
- 2006 : Takeda launches its own large-scale phase 3 clinical trial study that included more than 6000 patients to address the FDA’s safety concerns and prove that the drug is safe.
- 2008 : Results of Takeda’s own study is submitted to the FDA. The data provided shows that Uloric patients have no higher risks of heart problems than their competitor.
- 2009 : The FDA approves Uloric.
- 2012 : Based on adverse reaction reports to the FDA’s Medwatch System, the FDA issues a warning to Uloric patients and prescribing doctors of potential side effects that were previously unknown. The list of possible health risks included heart-related injuries.
- 2017 : The FDA performs its own safety clinical trial on Uloric and the preliminary results appear to indicate an increased risk of heart-related deaths in patients when compared to allopurinol. These results align with the FDA’s initial review of the medication in 2005 when it refused to clear the drug for approval.
- Aug 22, 2018 : The FDA announces that it has received the results of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial. An advisory committee is established to pore over the data and update the public regarding the safety of Uloric.
- Feb 21, 2019 : The FDA adds Black Box Warning to Uloric based on the CARES trial results and advisory committee stating that Uloric may increase patients’ risk of heart-related injuries and death.
Symptoms & Side Effects
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Trouble talking
- Sudden severe headache